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IRCT20260815070659N1 IRCT 2026-10-17 Yasouj University of Medical Sciences Effect of Oral Probiotics on Symptoms of Acute Treatment-Resistant Anal Fissure Effect of Oral Probiotics on Symptoms in Patients with Treatment-Resistant Acute Anal Fissure: A controlled Clinical Trial 2026-10-22 anticipated 60 Recruiting https://irct.ir/trial/93197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be allocated to the intervention and control groups using variable block randomization with block sizes of 2, 4, 6, and 8 and an allocation ratio of 1:1. The individual participant will be the unit of randomization. The random allocation sequence will be generated before participant recruitment using the online Sealed Envelope tool. The allocation sequence will be generated and maintained by an individual independent of participant recruitment and assessment. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes. After eligibility has been confirmed, informed consent has been obtained, and baseline assessments have been completed, the corresponding envelope will be opened in numerical order to reveal the participant’s group allocation, Blinding description: The study will be conducted using a double-blind design. The outcome assessor (surgeon) and data analyst will be blinded to group allocation and will be unaware of whether participants are assigned to the intervention or control group. The probiotic and placebo capsules will be identical in appearance, color, odor, and packaging. Participants will also be blinded to the intervention they receive. 2-3 Acute anal fissure. Intervention 1: Intervention group: Participants in the intervention group will receive an oral probiotic capsule (Bio IBS) (Takgene Zist Company), with each capsule containing three probiotic strains: *Lactobacillus casei*, *Lactobacillus rhamnosus*, and *Lactobacillus acidophilus*, providing a total of 5 × 10⁹ colony-forming units (CFU) per capsule. The probiotic will be administered twice daily for 8 weeks, in addition to standard treatment, including warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose. Intervention 2: Control group: Standard treatment, consisting of warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose, will be administered for 8 weeks + Placebo. Yes - There is a plan to make this available What will be shared: After the completion of the study, all study data will be shared after being de-identified When: One month after the completion of the intervention, the data of the main variables of the study will be shared. To whom: The study data will be available to academic and scientific researchers working at medical science centers. Conditions: Individuals associated with the medical and therapeutic fields may utilize the data from this study to conduct new research. Where to obtain: Via official email to the corresponding author at: majidahmadi1385@yahoo.com How to obtain: The applicant must submit their formal request via the organization's email to the responsible author's email address. The accountable author will provide the information to the applicant within a maximum of 2 weeks after the applicant confirms the information. Comments:
public Seyed Majid Ahmadi
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3323 5153 majidahmadi1385@yahoo.com Yasouj University of Medical Sciences scientific Seyed Majid Ahmadi
Shahid Zarei Educational Campus, Beach Park Towards Imam Sajjad (AS) Hospital, Yasuj
Yasuj Iran (Islamic Republic of) 7591875111 +98 74 3323 5153 majidahmadi1385@yahoo.com Yasouj University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years of age with physician-confirmed acute anal fissure Less than 6 weeks since symptom onset History of resistance to standard first-line treatment for 2 weeks 18 years 65 years Both History of hypersensitivity or allergy to probiotic components K60.0 Acute anal fissure Treatment - Other Treatment - Other Intervention group: Participants in the intervention group will receive an oral probiotic capsule (Bio IBS) (Takgene Zist Company), with each capsule containing three probiotic strains: *Lactobacillus casei*, *Lactobacillus rhamnosus*, and *Lactobacillus acidophilus*, providing a total of 5 × 10⁹ colony-forming units (CFU) per capsule. The probiotic will be administered twice daily for 8 weeks, in addition to standard treatment, including warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose. Control group: Standard treatment, consisting of warm sitz baths, topical diltiazem (Anti-Fissure) ointment, and lactulose, will be administered for 8 weeks + Placebo Pain. Timepoint: 2 weeks before the start of the intervention – 2 weeks after the end of the intervention. Method of measurement: visual analogue Scale (VAS). Pruritus ani. Timepoint: 2 weeks before the start of the intervention – 2 weeks after the end of the intervention. Method of measurement: visual analogue Scale (VAS). Bleeding. Timepoint: 2 weeks before the start of the intervention – 2 weeks after the end of the intervention. Method of measurement: Using a 4-point Likert scale. Yasouj University of Medical Sciences Approved 2026-07-15 Ethics committee of Yasuj University of Medical Sciences Daneshgah St., Motahari Blvd., Jahad Town Yasuj Kohgilouyeh-va-Boyrahmad Iran (Islamic Republic of)